Author + information
- Received November 18, 2019
- Revision received March 13, 2020
- Accepted March 23, 2020
- Published online May 18, 2020.
- Peter Sinnaeve, MD, PhDa,
- Gregor Fahrni, MDb,
- Dan Schelfaut, MDc,
- Alessandro Spirito, MDd,
- Christian Mueller, MDe,
- Jean-Marie Frenoux, PhDf,
- Abdel Hmissi, MScf,
- Corine Bernaud, MDf,
- Mike Ufer, MD, PhDf,
- Tiziano Moccetti, MDg,
- Shaul Atar, MDh,i and
- Marco Valgimigli, MD, PhDd,∗ (, )@vlgmrc
- aDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium
- bDepartment of Cardiology, University Hospital Basel, University Basel, Basel, Switzerland
- cCardiovascular Center Aalst, OLV-Clinic Aalst, Aalst, Belgium
- dDepartment of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland
- eDepartment of Cardiology and Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland
- fIdorsia Pharmaceuticals Ltd., Allschwil, Switzerland
- gCardiology Cardiocentro-Ticino, Lugano, Switzerland
- hDepartment of Cardiology, Galilee Medical Center, Nahariya, Israel
- iAzrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel
- ↵∗Address for correspondence:
Dr. Marco Valgimigli, Swiss Cardiovascular Center Bern, Bern University Hospital, University of Bern, Freiburgstrasse 4, Bern, Switzerland.
Background Oral P2Y12 receptor antagonists exhibit delayed onset of platelet inhibition in patients with acute myocardial infarction (AMI). Selatogrel is a potent, highly selective, and reversible P2Y12 receptor antagonist with a rapid onset and short duration of action.
Objectives This study sought to assess inhibition of platelet aggregation following subcutaneous administration of selatogrel in patients with AMI.
Methods Patients with AMI were randomized to a single subcutaneous dose of selatogrel of 8 or 16 mg. The primary endpoint was response to treatment (P2Y12 reaction units <100; measured by VerifyNow) at 30 min post-dose. Safety was assessed up to 48 h post-injection.
Results Forty-seven patients received selatogrel 8 mg (n = 24) or 16 mg (n = 23) followed by ticagrelor (n = 43) or clopidogrel (n = 1). The proportion of responders 30 min post-dose was 91% (one-sided 97.5% confidence interval [CI]: 80% to 100%) and 96% (97.5% CI: 87% to 100%) with 8 and 16 mg, respectively (p values for responders >85% target; p = 0.142 and p = 0.009, respectively). Response rates were independent from type of AMI presentation, age, or sex. A similar response rate was observed at 15 min (8 mg: 75% [97.5% CI: 58% to 100%]; 16 mg: 91% [97.5% CI: 80% to 100%]), which was sustained at 60 min post-dose (8 mg: 75% [97.5% CI: 58% to 100%]; 16 mg: 96% [97.5% CI: 87% to 100%]). At 15 min, median P2Y12 reaction units was 51 (range: 4 to 208) for 8 mg and 9 (range: 2 to 175) for 16 mg. Selatogrel was well tolerated, without major bleeding complications.
- acute coronary syndrome
- acute myocardial infarction
- non–ST-segment elevation myocardial infarction
- ST-segment elevation myocardial infarction
This study was sponsored by Idorsia Pharmaceuticals Ltd. Dr. Sinnaeve has received consultancy and/or speaker fees and grants from AstraZeneca and Daiichi-Sankyo all of which were collected institutionally; and is a clinical investigator for the Fonds voor Wetenschappelijk Onderzoek—Vlaanderen. Dr. Mueller has received grants and personal fees from Idorsia Pharmaceuticals Ltd. Dr. Frenoux, Mr. Hmissi, Dr. Bernaud, and Dr. Ufer are employees and shareholders of Idorsia Pharmaceuticals Ltd. Dr. Valgimigli has received grants and/or personal fees from AstraZeneca, Terumo, Alvimedica/CID, Abbott Vascular, Daiichi-Sankyo, Opsens, Bayer, CoreFLOW, Idorsia Pharmaceuticals Ltd., Universität Basel Department Klinische Forschung, Vifor, Bristol-Myers Squibb SA, iVascular, and Medscape. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received November 18, 2019.
- Revision received March 13, 2020.
- Accepted March 23, 2020.
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